ACADIA Pharmaceuticals Inc. — Nuplazid FDA Review (NDA207318, ORIG 1, 2016)
ACADIA Pharmaceuticals Inc. · 2016 · FDA Review (openFDA) · company profile →
Report summary
The FDA review of ACADIA Pharmaceuticals' Nuplazid (pimavanserin) for Parkinson's disease psychosis (PDP) involved multiple trials, including the pivotal ACP-103-020 study. While ACP-103-020 demonstrated statistically significant efficacy in reducing psychosis symptoms, the clinical benefit was deemed minimal. A major concern was the drug's safety profile, which showed a disproportionate increase in mortality and serious adverse events (SAEs) in the 34mg treatment group compared to placebo. Despite receiving Breakthrough Designation due to PDP being an unmet medical need, the increased risks of death and SAEs led to a recommendation against approval. The review also noted that pimavanserin did not significantly worsen motor symptoms of PD.
Key findings — cited to the page
| Irritability incidence | 0.3 % | · p.146 |
| Irritability incidence | 0.4 % | · p.146 |
| Risk difference for irritability (PIM 34mg vs Placebo) | -0.4 % | · p.146 |
| Risk difference for irritability (All PIM vs Placebo) | -0.2 % | · p.146 |
| Irritability incidence | 0.0 % | · p.146 |
| Improvement in CGI | 23.3 % | ACP 103-020 · p.14 |
| Change in CGI over placebo | -0.67 | ACP 103-020 · p.14 |
| Risk for serious adverse events including death (SAE) for pimavanserin 34mg vs. placebo | 2.38 | · p.15 |
| percentage of placebo arm patients with >= 3-point change in SAPS-PD total score | 44.2 % | · p.169 |
| median SAPS-PD change for much improvement (CGI-I=2) | 7 points | · p.168 |
| inter-rater correlation for SAPS | 0.936 | ACP-103-020 · p.171 |
| SAPS-PD mean difference from placebo | 3.06 points | ACP 103-020 · p.14 |
Source: ACADIA Pharmaceuticals Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →